← Product Code [CET](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CET) · K885078

# LIPASE SR LIQUID STABLE REAGENT SET (K885078)

_Medical Analysis Systems, Inc. · CET · Mar 13, 1989 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CET/K885078

## Device Facts

- **Applicant:** Medical Analysis Systems, Inc.
- **Product Code:** [CET](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CET.md)
- **Decision Date:** Mar 13, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1465
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A lipase test system is a device intended to measure the activity of the enzymes lipase in serum. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CET/K885078](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CET/K885078)

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